Inovio Pharmaceuticals Initiates DNA Immunotherapy Trial for Breast, Lung and Pancreatic Cancers

Active Immunotherapy Targets hTERT Gene Associated with 85% of Cancers

Preclinical Studies Showed Tumor Shrinkage and Prevention of Tumor Recurrence

Dec 18, 2014, 06:00 ET from Inovio Pharmaceuticals, Inc.

PLYMOUTH MEETING, Pa., Dec. 18, 2014 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced it has initiated a phase I trial of its hTERT DNA immunotherapy (INO-1400) alone or in combination with Inovio's IL-12 immune activator (INO-9012) in adults with breast, lung, or pancreatic cancer at high risk of relapse after surgery and other cancer treatments. Because high levels of hTERT (human telomerase reverse transcriptase) expression are found in 85% of human cancers, Inovio's cancer candidate holds the potential as a broad spectrum cancer therapeutic.

A previously published study of this product showed that administration in monkeys, whose TERT is 96% similar to human TERT, generated strong and broad TERT-specific immune responses and demonstrated the potential to eliminate tumor cells. Mice immunized with Inovio's DNA immunotherapy experienced delayed tumor growth, tumor shrinkage, and longer overall survival compared with non-immunized mice.

This human trial is an open label, dose escalation study in subjects with breast, lung, or pancreatic cancer at high risk of relapse after surgery and other treatments including chemotherapy and radiation. Approximately 54 subjects will be enrolled into one of six treatment groups and receive INO-1400 alone or in combination with INO-9012, Inovio's immune activator. The study will be conducted at the University of Pennsylvania's Abramson Cancer Center, which will fund all site-specific clinical study costs.

Lung, breast, and pancreatic cancer mortality rates are ranked first, third, and fourth, respectively, among cancer types in the United States, despite improvement in detection and treatment. In each of these three cancer types, significant numbers of patients undergo surgical resection and adjuvant therapy with an attempt at cure, but only a fraction remain in remission. This study will evaluate Inovio's novel immunotherapy with the ultimate goal of reducing the risk of relapse in these patients.

Robert Vonderheide, MD, DPhil, said, "The next great wave of oncology advancements will be treatments which empower the patient's own immune system to seek and destroy cancer. In this study we will evaluate a new immunotherapy targeting the hTERT gene found in numerous cancers."  Dr. Vonderheide is Professor of Medicine; Hanna Wise Professor in Cancer Research; Associate Director for Translational Research, Abramson Cancer Center; Vice Chief for Research, Hematology-Oncology Division, Department of Medicine.

Dr. J. Joseph Kim, President and CEO, said, "We are enthusiastic about the potential use of INO-1400 cancer immunotherapy in multiple major cancers, given that hTERT is expressed in the vast majority of cancer types yet is rare in normal cells. INO-1400 therapy adds to Inovio's growing oncology franchise led by our phase III candidate, VGX-3100, for treating HPV-related pre-cancers and cancers."  

The primary objective of this study is to evaluate the safety and tolerability of INO-1400 alone or in combination with INO-9012, delivered intramuscularly in subjects with high-risk breast, lung, or pancreatic cancer with no evidence of disease after surgery and adjuvant therapy. The secondary objectives are to evaluate cellular and humoral immune responses, measure time to disease progression, and evaluate immunotherapy-induced changes in subjects.

About Inovio's Cancer Immunotherapies

Inovio's DNA-based immunotherapy technology uniquely activates and multiplies in the body highly potent antigen-specific killer T cells targeting a specific cancer. The company's technology provides the most natural interaction with the immune system next to an actual infection, therefore the activated therapeutic response remains controlled by the immune system and has to date not triggered unwanted inflammatory responses. These are ideal characteristics of an immuno-oncology product. The immune system uses the same weapons to fight precancerous and cancerous cells – sometimes the immune system simply requires assistance to mount an effective immune response.  Inovio achieved an industry first with clinically significant efficacy shown with its VGX-3100 HPV immunotherapy in a phase II study of cervical precancer. Inovio is now advancing multiple clinical and R&D stage active immunotherapies with the potential to address the full spectrum of precancers and cancers.

About Inovio Pharmaceuticals, Inc.

Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include Roche, MedImmune, University of Pennsylvania, DARPA, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.

This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, including safety and efficacy for VGX-3100, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon® active immune therapy and vaccine products, our ability to advance our portfolio of immune-oncology products independently, including INO-5150, and to commence a phase I clinical trial for INO-5150 in the first half of 2015, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, our ability to enter into partnerships in conjunction with our research and development programs, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2013, our Form 10-Q for the quarter ended September 30, 2014, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.

CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com 
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com

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SOURCE Inovio Pharmaceuticals, Inc.



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